Cigna Medical Coverage Policy Subject

Local Injection Therapy and Neurosurgery for Cervicogenic Headache and Occipital Neuralgia

Table of Contents Coverage Policy .................................................. 1 General Background ........................................... 2 Coding/Billing Information ................................... 7 References .......................................................... 9

Effective Date ............................ 5/15/2014 Next Review Date ...................... 5/15/2015 Coverage Policy Number ................. 0063 Hyperlink to Related Coverage Policies Acupuncture Biofeedback Botulinum Therapy Chiropractic Care Electrical Stimulation and Therapy Devices Minimally Invasive Treatment of Back and Neck Pain Omnibus Codes Physical Therapy

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna companies. Coverage Policies are intended to provide guidance in interpreting certain standard Cigna benefit plans. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Proprietary information of Cigna. Copyright ©2014 Cigna

Coverage Policy Cigna does not cover ANY of the following local injection therapies, ablative treatments, electrical stimulation or neurosurgeries for the treatment of cervicogenic headache or occipital neuralgia because these interventions are considered experimental, investigational or unproven (this list may not be allinclusive): • • • • • • • • • • • • •

botulinum toxin type A* cervical microdecompression surgery (Jho Procedure) cryodenervation discectomy and spinal fusion electrical stimulation of occipital nerve ganglionectomy nerve root decompression neurectomy occipital nerve neurolysis pulsed radiofrequency ablation radiofrequency ablation radiofrequency denervation radiofrequency neurotomy

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•

rhizotomy

*For additional information on the use of botulinum toxin type A, refer to the Coverage Policy Botulinum Therapy.

General Background Cervicogenic headache and occipital neuralgia are syndromes whose diagnosis and treatment have been reported as controversial in the medical literature due to lack of expert consensus regarding their etiology and treatment. The terminology refers to specific types of headache thought to arise from impingement or entrapment of the occipital nerves and/or the upper spinal vertebrae. Compression and injury of the occipital nerves within the muscles of the neck and compression of the second and third cervical nerve roots are generally thought to be responsible for the symptoms, including unilateral and occasionally bilateral head, neck and arm pain. The convergence of the afferents of the upper three cervical spinal nerves is thought to be responsible for this head pain that arises from the neck. Generally accepted causes of head pain originating in the neck include: developmental abnormalities, tumors, ankylosing spondylitis, rheumatoid arthritis, and osteomyelitis. Controversial causes include: cervical disc herniations, degenerative disc disease, and whiplash injuries (Zhaou, 2012; Evans, 2004; Biondi, 2001; Vincent, et al., 1998; Bogduk, 2001). The International Headache Society (IHS), through expert consensus, created a headache classification system designed to provide a uniform nomenclature for diagnosis of individual headache. The IHS criteria are regarded as the gold standard for diagnosis of all types of headaches. Headache and facial pain are classified by the IHS into primary, secondary, and other etiologies. Primary headaches are without obvious causative factors and include migraine, tension and cluster headaches. The secondary headaches include headaches attributed to disorders of the head and neck (i.e., cervicogenic headache) and cranial neuralgias (i.e., occipital neuralgia). The IHS notes that tumors, fractures, infections and rheumatoid arthritis of the upper cervical spine have not been validated formally as causes of headache but are accepted. Cervical spondylosis and osteochondritis are not accepted valid causes (Taylor, 2004; IHS, 2004). Cervicogenic Headache The clinical features of cervicogenic headache may mimic those associated with primary headache disorders (e.g., tension-type headache, migraine, or hemicrania continua), making it difficult to distinguish among headache types. Cervicogenic headache is characterized by continuous, unilateral head pain radiating from the occipital areas to the frontal area, with associated neck pain and ipsilateral shoulder or arm pain. The headache is moderate in intensity with a non-throbbing character. It is described as a dull, boring, dragging pain that can fluctuate in intensity. The duration of headache may range from a few hours to several days and, in some cases, several weeks. The pain is exacerbated by neck movements and is usually caused by neck trauma. Associated symptoms, such as nausea, photophobia, phonophobia, dizziness, blurred vision, and dysphagia, may be present but are generally not pronounced (Kwiatkowski, 2014; Biondi, 2005; Martelletti, 2004; Peters, 2004). The IHS considers the diagnostic criteria for cervicogenic headache as follows (IHS, 2004): • • • •

pain referred from a source in the neck and perceived in one or more regions of the head and/or face clinical, laboratory and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be, or generally accepted as, a valid cause of headache evidence that the pain can be attributed to the neck disorder or lesion, based on either clinical signs that implicate a source of pain in the neck or abolition of headache following diagnostic nerve block pain resolving within three months after successful treatment of causative disorder or lesion

Occipital Neuralgia Occipital neuralgia is one type of cervicogenic headache described as pain in the distribution of the greater and lesser occipital nerves, associated with posterior scalp dysesthesia or hyperalgesia. The pain is described as a lancinating, sharp, throbbing, electric shock–like pain. Two broad categories of individuals with occipital neuralgia are those with structural pathologic changes and those without an apparent cause. Proposed causes include myofascial tightening, trauma of C2 nerve root (whiplash injury), prior skull or suboccipital surgery, other type of nerve entrapment, idiopathic causes, hypertrophied atlantoepistrophic (C1-2) ligament, sustained neck

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muscle contractions, and spondylosis of the cervical facet joints. Most patients with occipital neuropathy do not have discernible lesions. Occipital neuralgia may occur as an intermittent or a continuous headache. In continuous occipital neuralgia, the headaches may be further classified as acute or chronic. In general, there are no neurologic deficits from occipital neuralgia. However, the pain may result in significant limitations in activities of daily living. The diagnosis of occipital neuralgia is generally made clinically on the basis of history and physical examination. Imaging may help confirm the diagnosis when there is an anatomic cause. Diagnostic local anesthetic nerve blocks may be required for a definitive diagnosis to be obtained; these blocks are done with or without the addition of corticosteroid. The relief of pain after a diagnostic local anesthetic block of the greater and lesser occipital nerves is generally confirmatory of the diagnosis of occipital neuralgia (Singla, 2008). The IHS considers the diagnostic criteria for occipital neuralgia as follows (IHS, 2004): • • •

paroxysmal, stabbing pain, with or without persistent aching between paroxysms, in the distribution(s) of the greater, lesser and/or third occipital nerves tenderness over the affected nerve pain eased temporarily by local anesthetic block of the nerve

Treatments Numerous treatments for cervicogenic headache and occipital neuralgia have been proposed, with varying levels of success. The consensus on standard treatment does not exist, because of the variability in patient selection and clinical outcomes. Pharmacological treatment with oral analgesics, anti-inflammatory medications, tricyclic antidepressants, and anticonvulsant medications have been used alone or in combination with other treatment modalities. Other methods suggested are: the use of a cervical collar during the acute phase; physical therapy with stretching and strengthening exercises; postural training; relaxation exercises; transcutaneous nerve stimulation (TENS); and manual therapy, including spinal manipulation and spinal mobilization (Bogduk, et al., 2009; Singla, 2008; Biondi, 2005, 2001; Martelletti, et al., 2004). In a review of medical textbooks, commonly used treatments for pain relief from cervicogenic headache and occipital neuralgia include the use of local injected anesthetics, with or without the addition of corticosteroid preparation, to block the affected nerve(s). It is noted that these injections can be used as therapeutic treatment measures for pain relief, although the duration of pain relief varies from hours to months. However, the scientific evidence regarding injection therapy or percutaneous nerve block for occipital neuralgia and cervicogenic headache has been limited (Zhaou, 2012; Singla, 2008; Peters, 2004; Chavin, 2003). Pharmacological and alternative treatment modalities are not effective for some individuals, and therefore other methods have been proposed, such as local injections of anesthetics and/or steroids and epidural steroid ® injections. Botulinum Toxin Type A (Botox A) has been investigated as a treatment of occipital neuralgia and cervicogenic headaches (Kapural, et al., 2007; Freund, et al., 2000). Ablative treatments (e.g., pulsed radiofrequency ablation, radiofrequency ablation, radiofrequency neurotomy, radiofrequency denervation, neurolysis, cryodenervation, nerve root shizotomy) have been investigated attempt to denervate the occipital and/or upper cervical nerve. Surgical interventions have been investigated as a treatment option to relieve impingement of the nerve root(s) and thereby eliminate symptoms caused by compression and injury to the cervical nerves, including but not limited to, ganglionectomy, nerve root decompression, cervical microdecompression ((Jho Procedure) (Zhang, et al., 2011; Ducic, et al., 2009; Lee, et al., 2007; Haspeslagh, et al., 2006; Gille, et al., 2004; Wang, et al., 2002; ; Biondi, 2001; Freund, et al., 2000; Jansen, 2000; Reale, et al., 2000; Sjaastad, et al., 2000; van Suijlekom, et al., 2000; Pikus, et al., 1996; Anthony, 1992; Bovim, et al., 1992b; Koch, et al., 1992). Electrical stimulation has been proposed as a treatment for occipital neuralgia. Electrical stimulation can be delivered transcutaneously, percutaneously and by using an implantable device. Peripherally implanted nerve stimulation entails the placement of electrodes near or on a selected peripheral nerve such as the occipital nerves at the base of the head. Percutaneous or open implantation of a neurostimulator electrode array is a technique being investigated for treatment of chronic pain such as occipital neuralgia. Electrical stimulation is delivered by a pulse generator and an electrode that is placed subcutaneously at the site of maximum pain rather than at the site of the nerve. This technique also referred to as subcutaneous target stimulation or peripheral nerve field stimulation. Page 3 of 12 Coverage Policy Number: 0063

For information on the coverage of peripheral nerve field stimulation for the treatment of chronic pain, please refer to the Cigna HealthCare Coverage Position, Omnibus Codes. Literature Review Local Injection Therapy There is a lack of well-designed, randomized control studies in the peer-reviewed literature relating to Botox A therapy as an effective treatment for cervicogenic headache or occipital neuralgia. The limited evidence comes primarily from small retrospective case series studies. Long term outcomes have not been reported in the studies. Further controlled studies are required to assess the efficacy of this approach in a large series of patients with cervicogenic headache or occipital neuralgia (Kapural et al., 2007; Martelleti, et al., 2004; Freund, et al., 2000; Hobson, et al., 1997). For information on the coverage of Botox A for the treatment of occipital neuralgia or cervicogenic headache, please refer to the Cigna HealthCare Coverage Position, Botunlinum Therapy. Neurosurgery A number of different surgical procedures have been investigated for the treatment of occipital neuralgia and cervicogenic headache. Several small retrospective case series studies have reported positive effects of various surgical treatments. However, there were recurrences of pain and varying levels of pain relief and duration. No specific characteristics could be identified that were predictive of a positive outcome or sustained response to treatment. Larger studies with longer periods of follow-up are needed to confirm the benefits reported in the available studies. In a retrospective chart review, Pisapia et al. (2012) evaluated 29 patients who had undergone C2 nerve root decompression (n=11), C2 dorsal root ganglionectomy (n=10), or decompression followed by ganglionectomy (n=8). The overall results stated that 19 of 29 patients (66%) experienced a good or excellent outcome at most recent follow-up. A total of 34% of the patients reported poor outcome in that the headache was unchanged or worse at a mean follow-up of 45 months. Of the 19 patients who completed the telephone questionnaire (mean follow-up 5.6 years), patients undergoing decompression, ganglionectomy, or decompression followed by ganglionectomy experienced similar outcomes. Of 19 telephone responders, 68% rated overall operative results as very good or satisfactory and 37% poor rated overall operative results as unchanged or worse. The study was limited by its size and lack of control group. In a retrospective chart review, Acar et al. (2008) evaluated 20 patients who had undergone C2 and/or C3 ganglionectomies for intractable occipital pain. Patients were interviewed regarding pain relief, pain relief duration, functional status, medication usage and procedure satisfaction, preoperatively, immediately postoperative, and at follow-up (mean 42.5 months). C2, C3 and consecutive ganglionectomies at both levels were performed on 4, 5, and 11 patients, respectively. All patients reported preoperative pain relief following cervical nerve blocks. Average visual analog scale scores were 9.4 preoperatively and 2.6 immediately after procedure. Ninety-five percent of patients reported short-term pain relief (